Seizures: Seizures have been reported in patients receiving tramadol within the recommended dosage range. Spontaneous post-marketing reports indicate that seizure risk is increased with doses of tramadol above the recommended range. Concomitant use of tramadol increases the seizure risk in patients taking: Selective serotonin reuptake inhibitors (SSRI antidepressants or anorectics), tricyclic antidepressants (TCAs) and other tricyclic compounds (eg, cyclobenzaprine, promethazine, etc) or opioids.
Administration of tramadol may enhance the seizure risk in patients taking: MAO inhibitors, neuroleptics or other drugs that reduce the seizure threshold.
Risk of convulsions may also increase in patients with epilepsy, those with a history of seizures or in patients with a recognized risk for seizure (eg, head trauma, metabolic disorders, alcohol and drug withdrawal, CNS infections). In tramadol overdose, naloxone administration may increase the risk of seizure.
Anaphylactoid Reactions: Patients with a history of anaphylactoid reactions to codeine and other opioids may be at increased risk and therefore should not receive Ultracet.
Respiratory Depression: Administer Ultracet cautiously in patients at risk for respiratory depression. When large doses of tramadol are administered with anesthetic medications or alcohol, respiratory depression may result. Treat such cases as an overdose. If naloxone is to be administered, use cautiously because it may precipitate seizures.
Use with CNS Depressants: Ultracet should be used with caution and in reduced dosages when administered to patients receiving CNS depressants eg, alcohol, opioids, anesthetic agents, phenothiazines, tranquilizers or sedative hypnotics.
Increased Intracranial Pressure or Head Trauma: Ultracet should be used with caution in patients with increased intracranial pressure or head injury.
Use in Opioid-Dependent Patients: Ultracet should not be used in opioid-dependent patients. Tramadol has been shown to reinitiate physical dependence in some patients that have been previously dependent on other opioids.
Use with Alcohol: Chronic heavy alcohol abusers may be at increased risk of liver toxicity from excessive paracetamol use.
Withdrawal: Withdrawal symptoms may occur if Ultracet is discontinued abruptly. Panic attacks, severe anxiety, hallucinations, paraesthesia, tinnitus and unusual CNS symptoms have also been very rarely reported with abrupt discontinuation of tramadol HCl. Clinical experience suggests that withdrawal symptoms may be relieved by tapering the medication.
Use with MAO Inhibitors and Serotonin Reuptake Inhibitors: Use Ultracet with great caution in patients taking MAO inhibitors. Concomitant use of tramadol with MAO inhibitors or SSRIs increases the risk of adverse events, including seizure and serotonin syndrome.
Use in Renal Disease: Ultracet has not been studied in patients with impaired renal function. In patients with creatinine clearances of <30 mL/min, it is recommended that the dosing interval be increased not to exceed 2 tablets every 12 hrs.
Use in Hepatic Disease: The use in patients with severe hepatic impairment is not recommended.
General Precautions: The recommended dose of Ultracet should not be exceeded.
Ultracet should not be co-administered with other tramadol- or paracetamol-containing products.
Effects on the Ability to Drive or Operate Machinery: Ultracet may impair mental or physical abilities required for the performance of potentially hazardous tasks eg, driving a car or operating machinery.
Use in children: The safety and effectiveness of Ultracet has not been established in the pediatric population (children <16 years).